{"id":255,"date":"2020-01-16T04:49:00","date_gmt":"2020-01-16T04:49:00","guid":{"rendered":"https:\/\/sagaciousresearch.com\/blog\/?p=255"},"modified":"2025-11-20T07:43:13","modified_gmt":"2025-11-20T07:43:13","slug":"secondary-patenting-or-evergreening-india","status":"publish","type":"post","link":"https:\/\/sagaciousresearch.com\/blog\/secondary-patenting-or-evergreening-india","title":{"rendered":"Secondary Patenting or Evergreening: Indian IP perspective"},"content":{"rendered":"\n<p>For years, India has refused rampant secondary patenting or evergreening of patents of foreign pharmaceutical companies as per Section 3(d) of Indian law of <a href=\"http:\/\/www.ipindia.nic.in\/writereaddata\/Portal\/IPOAct\/1_31_1_patent-act-1970-11march2015.pdf\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">The Patents Act, 1970<\/a>. The evergreening of patents is a practice of tweaking of drugs in order to<a aria-label=\" (opens in a new tab)\" href=\"https:\/\/sagaciousresearch.com\/patent-term-adjustment\" target=\"_blank\" rel=\"noreferrer noopener\"> extend their patent term<\/a> and thus their profitability. India, by prohibiting evergreening, is not only helping the growth of domestic generic drug makers but also helping millions of people who can hardly afford the high-priced modified drugs.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_81 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69db19292efe2\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69db19292efe2\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/sagaciousresearch.com\/blog\/secondary-patenting-or-evergreening-india\/#Primary_Patenting\" >Primary Patenting<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/sagaciousresearch.com\/blog\/secondary-patenting-or-evergreening-india\/#Evergreening_or_Secondary_patenting_Emergence\" >Evergreening or Secondary patenting Emergence<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/sagaciousresearch.com\/blog\/secondary-patenting-or-evergreening-india\/#Indias_take_on_evergreening_or_secondary_patenting\" >India\u2019s take on evergreening or secondary patenting<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/sagaciousresearch.com\/blog\/secondary-patenting-or-evergreening-india\/#Having_Queries_Contact_Us_Now\" >Having Queries? Contact Us Now!<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Primary_Patenting\"><\/span>Primary Patenting<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Every drug entering the marketplace has a long history, which starts from its initial stages of development to appearing on the countertop at our local pharmacist. The first step which these inventors and pharmaceutical corporations take, starts with seeking protection of the discovered drug in the form of a patent, referred to as a primary patent. Protection in the form of a patent spurs innovation by providing incentive to the inventors for the discovery along with granting a monopoly to the drug in the market for 20 years.<\/p>\n\n\n\n<p><strong>Also Read:<\/strong> <a href=\"https:\/\/sagaciousresearch.com\/blog\/patents-protect-pharmaceutical-innovation\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">How Patents Help Protect Pharmaceutical Innovation<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Evergreening_or_Secondary_patenting_Emergence\"><\/span>Evergreening or Secondary patenting Emergence<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Expiration of 20 years of patents paves path for the entry of generic pharmaceutical drug that is equivalent to a branded drug in dosage, strength, route of administration, quality, performance, and intended use. However, it does not carry the brand name, hence are sold at cheaper prices. However, the entry of generics slows down the market for such big pharmaceutical companies.<\/p>\n\n\n\n<p>The threat of this steep fall in profits that is driven by the sale of their blockbuster drugs urges pharmaceutical companies to find new ways to postpone their exclusivity. Over the past few decades, companies have used a process known as secondary patenting or evergreening to keep generic companies out of the market for longer so that they can reap the benefits of their drugs for a longer period than the stipulated 20 years. Secondary patenting or evergreening is achieved by seeking extra patents on modifications of the original drug: new forms of release, new dosages, new combinations or new forms. This strategy is most effective and lucrative when employed for protection of their blockbuster medicines, which reap handsome annual revenues. However, these secondary patents achieved after tweaking of the original patents meet very low thresholds of <a href=\"https:\/\/sagaciousresearch.com\/patentability-search\/\" target=\"_blank\" rel=\"noreferrer noopener\">novelty<\/a> and inventiveness and the improvement in the health outcomes are small or non-existent, as per critics.<\/p>\n\n\n\n<p>These provisions of secondary patenting also extend to biologics (highly effective drugs produced within living micro-organisms, sold at higher costs) &#8211; the new big players in the therapeutics market. The complexity of biological molecules demands filing of many patents for one drug thus increasing the price at which it is available to the public. Thus, in order to help the big giants earn profits while maintaining the prices of the drugs. many countries like the U.S the patent laws play an important role in the emergence of practices like evergreening.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Indias_take_on_evergreening_or_secondary_patenting\"><\/span>India\u2019s take on evergreening or secondary patenting<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The U.S. IP law recognizes, accepts and promotes evergreening which has proved profitable for the big giants who have been extending exclusivity by bringing in variations of their already patentable drugs in the market. India, however, does not allow evergreening. For example, <a href=\"https:\/\/www.abbvie.com\/\" target=\"_blank\" rel=\"noreferrer noopener nofollow\"><strong>AbbVie<\/strong><\/a>, a pharma giant has increased the price of Humira, world\u2019s best-selling Biologic prescription drug in the U.S. by 100% by many of secondary patents. Humira costs $1,300 (Rs. 85,000) in the U.S.; the same treatment costs only $200 (Rs. 13,500) in India because of the rejection of secondary patents on Humira by the <a href=\"http:\/\/www.ipindia.nic.in\/\" target=\"_blank\" rel=\"noreferrer noopener nofollow\"><strong>Indian Patent Office<\/strong><\/a> (IPO) and the consequent allowance of cheaper versions to enter the market.<\/p>\n\n\n\n<p><a href=\"http:\/\/www.ipindia.nic.in\/writereaddata\/Portal\/IPOAct\/1_31_1_patent-act-1970-11march2015.pdf\" target=\"_blank\" rel=\"noreferrer noopener nofollow\"><strong>Section 3(d) of The Patents Act, 1970<\/strong><\/a> reads that \u201cthe mere discovery of a new form of a known substance or the discovery of any new property or new use for a known substance or of the use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant is not patentable\u201d. So, Indian IP law can be regarded as an innovation in its own right, which deals specifically with such inventions. Indian IP laws are setting an example and leading the charge on curbing evergreening, thereby safeguarding its access of generic drugs to the general public for a bigger cause, i.e., public health.<\/p>\n\n\n\n<p>&#8211; Harsha Agarwal and The Editorial Team<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Having_Queries_Contact_Us_Now\"><\/span>Having Queries? Contact Us Now!<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\nvar gform;gform||(document.addEventListener(\"gform_main_scripts_loaded\",function(){gform.scriptsLoaded=!0}),document.addEventListener(\"gform\/theme\/scripts_loaded\",function(){gform.themeScriptsLoaded=!0}),window.addEventListener(\"DOMContentLoaded\",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,themeScriptsLoaded:!1,isFormEditor:()=>\"function\"==typeof InitializeEditor,callIfLoaded:function(o){return!(!gform.domLoaded||!gform.scriptsLoaded||!gform.themeScriptsLoaded&&!gform.isFormEditor()||(gform.isFormEditor()&&console.warn(\"The use of gform.initializeOnLoaded() is deprecated in the form editor context and will be removed in Gravity Forms 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id='input_203_17' class='large gfield_select'    aria-required=\"true\" aria-invalid=\"false\" ><option value='' >Please Select Country<\/option><option value='United States' >United States<\/option><option value='Canada' >Canada<\/option><option value='United Kingdom' >United Kingdom<\/option><option value='China' >China<\/option><option value='India' >India<\/option><option value='North Korea' >North Korea<\/option><option value='South korea' >South korea<\/option><option value='United Arab Emirates' >United Arab Emirates<\/option><option value='Afghanistan' >Afghanistan<\/option><option value='Albania' >Albania<\/option><option value='Algeria' >Algeria<\/option><option value='Andorra' >Andorra<\/option><option value='Angola' >Angola<\/option><option value='Antigua and Barbuda' >Antigua and Barbuda<\/option><option value='Argentina' >Argentina<\/option><option value='Armenia' >Armenia<\/option><option value='Australia' >Australia<\/option><option value='Austria' 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Republic' >Central African Republic<\/option><option value='Chad' >Chad<\/option><option value='Chile' >Chile<\/option><option value='Colombia' >Colombia<\/option><option value='Comoros' >Comoros<\/option><option value='Congo' >Congo<\/option><option value='Costa Rica' >Costa Rica<\/option><option value='C\u00f4te d\u2019Ivoire' >C\u00f4te d\u2019Ivoire<\/option><option value='Croatia' >Croatia<\/option><option value='Cuba' >Cuba<\/option><option value='Cyprus' >Cyprus<\/option><option value='Czech Republic' >Czech Republic<\/option><option value='Denmark' >Denmark<\/option><option value='Djibouti' >Djibouti<\/option><option value='Dominica' >Dominica<\/option><option value='Dominican Republic' >Dominican Republic<\/option><option value='East Timor (Timor-Leste)' >East Timor (Timor-Leste)<\/option><option value='Ecuador' >Ecuador<\/option><option value='Egypt' >Egypt<\/option><option value='El Salvador' >El Salvador<\/option><option value='Equatorial Guinea' >Equatorial Guinea<\/option><option value='Eritrea' >Eritrea<\/option><option value='Estonia' >Estonia<\/option><option value='Eswatini' >Eswatini<\/option><option value='Ethiopia' >Ethiopia<\/option><option value='Fiji' >Fiji<\/option><option value='Finland' >Finland<\/option><option value='France' >France<\/option><option value='Gabon' >Gabon<\/option><option value='The Gambia' >The Gambia<\/option><option value='Georgia' >Georgia<\/option><option value='Germany' >Germany<\/option><option value='Ghana' >Ghana<\/option><option value='Greece' >Greece<\/option><option value='Grenada' >Grenada<\/option><option value='Guatemala' >Guatemala<\/option><option value='Guinea' >Guinea<\/option><option value='Guinea-Bissau' >Guinea-Bissau<\/option><option value='Guyana' >Guyana<\/option><option value='Haiti' >Haiti<\/option><option value='Honduras' >Honduras<\/option><option value='Hungary' >Hungary<\/option><option value='Iceland' >Iceland<\/option><option value='Indonesia' >Indonesia<\/option><option value='Iran' >Iran<\/option><option value='Iraq' >Iraq<\/option><option value='Ireland' >Ireland<\/option><option value='Israel' >Israel<\/option><option value='Italy' >Italy<\/option><option value='Jamaica' >Jamaica<\/option><option value='Japan' >Japan<\/option><option value='Jordan' >Jordan<\/option><option value='Kazakhstan' >Kazakhstan<\/option><option value='Kenya' >Kenya<\/option><option value='Kiribati' >Kiribati<\/option><option value='Kosovo' >Kosovo<\/option><option value='Kuwait' >Kuwait<\/option><option value='Kyrgyzstan' >Kyrgyzstan<\/option><option value='Laos' >Laos<\/option><option value='Latvia' >Latvia<\/option><option value='Lebanon' >Lebanon<\/option><option value='Lesotho' >Lesotho<\/option><option value='Liberia' >Liberia<\/option><option value='Libya' >Libya<\/option><option value='Liechtenstein' >Liechtenstein<\/option><option value='Lithuania' >Lithuania<\/option><option value='Luxembourg' >Luxembourg<\/option><option value='Madagascar' >Madagascar<\/option><option value='Malawi' >Malawi<\/option><option value='Malaysia' >Malaysia<\/option><option value='Maldives' >Maldives<\/option><option value='Mali' >Mali<\/option><option value='Malta' >Malta<\/option><option value='Marshall Islands' >Marshall Islands<\/option><option value='Mauritania' >Mauritania<\/option><option value='Mauritius' >Mauritius<\/option><option value='Mexico' >Mexico<\/option><option value='Micronesia' >Micronesia<\/option><option value='Moldova' >Moldova<\/option><option value='Monaco' >Monaco<\/option><option value='Mongolia' >Mongolia<\/option><option value='Montenegro' >Montenegro<\/option><option value='Morocco' >Morocco<\/option><option value='Mozambique' >Mozambique<\/option><option value='Myanmar (Burma)' >Myanmar (Burma)<\/option><option value='Namibia' >Namibia<\/option><option value='Nauru' >Nauru<\/option><option value='Nepal' >Nepal<\/option><option value='Netherlands' >Netherlands<\/option><option value='New Zealand' >New Zealand<\/option><option value='Nicaragua' >Nicaragua<\/option><option value='Niger' >Niger<\/option><option value='Nigeria' >Nigeria<\/option><option value='North Macedonia' >North Macedonia<\/option><option value='Norway' >Norway<\/option><option value='Oman' >Oman<\/option><option value='Pakistan' >Pakistan<\/option><option value='Palau' >Palau<\/option><option value='Panama' >Panama<\/option><option value='Papua New Guinea' >Papua New Guinea<\/option><option value='Paraguay' >Paraguay<\/option><option value='Peru' >Peru<\/option><option value='Philippines' >Philippines<\/option><option value='Poland' >Poland<\/option><option value='Portugal' >Portugal<\/option><option value='Qatar' >Qatar<\/option><option value='Romania' >Romania<\/option><option value='Russia' >Russia<\/option><option value='Rwanda' >Rwanda<\/option><option value='Saint Kitts and Nevis' >Saint Kitts and Nevis<\/option><option value='Saint Lucia' >Saint Lucia<\/option><option value='Saint Vincent and the Grenadines' >Saint Vincent and the Grenadines<\/option><option value='Samoa' >Samoa<\/option><option value='San Marino' >San Marino<\/option><option value='Sao Tome and Principe' >Sao Tome and Principe<\/option><option value='Saudi Arabia' >Saudi Arabia<\/option><option value='Senegal' >Senegal<\/option><option value='Serbia' >Serbia<\/option><option value='Seychelles' >Seychelles<\/option><option value='Sierra Leone' >Sierra Leone<\/option><option value='Singapore' >Singapore<\/option><option value='Slovakia' >Slovakia<\/option><option value='Slovenia' >Slovenia<\/option><option value='Solomon Islands' >Solomon Islands<\/option><option value='Somalia' >Somalia<\/option><option value='South Africa' >South Africa<\/option><option value='Spain' >Spain<\/option><option value='Sri Lanka' >Sri Lanka<\/option><option value='Sudan' >Sudan<\/option><option value='South Sudan' >South Sudan<\/option><option value='Suriname' >Suriname<\/option><option value='Sweden' >Sweden<\/option><option value='Switzerland' >Switzerland<\/option><option value='Syria' >Syria<\/option><option value='Taiwan' >Taiwan<\/option><option value='Tajikistan' >Tajikistan<\/option><option value='Tanzania' >Tanzania<\/option><option value='Thailand' >Thailand<\/option><option value='Togo' >Togo<\/option><option value='Tonga' >Tonga<\/option><option value='Trinidad and Tobago' >Trinidad and Tobago<\/option><option value='Tunisia' >Tunisia<\/option><option value='Turkey' >Turkey<\/option><option value='Turkmenistan' >Turkmenistan<\/option><option value='Tuvalu' >Tuvalu<\/option><option value='Uganda' >Uganda<\/option><option value='Ukraine' >Ukraine<\/option><option value='Uruguay' >Uruguay<\/option><option value='Uzbekistan' >Uzbekistan<\/option><option value='Vanuatu' >Vanuatu<\/option><option value='Vatican City' >Vatican City<\/option><option value='Venezuela' >Venezuela<\/option><option value='Vietnam' >Vietnam<\/option><option value='Yemen' >Yemen<\/option><option value='Zambia' 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